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Rist™ 079
Radial Access Guide Catheter
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Table Of Contents
Rist™ 079 Radial Access Guide Catheter
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Symbol Glossary...................................................................... 4
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English
en
Instructions for Use
CAUTION
Federal Law (USA) restricts this device to sale by or on the order of a physician.
DEVICE DESCRIPTION
The Rist™ 079 Radial Access Guide Catheter is a single lumen, exible, variable stiness long sheath. It
has a radiopaque marker band on the distal end and a Luer hub at the proximal end. The Rist™ 079 Radial
Access Guide Catheter shaft has a 25cm lubricious coating at the distal end to reduce friction during use.
Each package includes one Rist™ 079 Radial Access Guide Catheter and one Dilator. Dimensions of the Rist™
079 Radial Access Guide Catheter are included on the individual device label.
DEVICE COMPATIBILITY
The inner lumen of the Rist™ 079 Radial Access Guide Catheter is compatible with 6F (0.078inch OD or
1.99mm OD) or smaller catheters.
INTENDED PURPOSE/INDICATIONS FOR USE
The Rist™ 079 Radial Access Guide Catheter is indicated for the introduction of interventional devices into
the peripheral, coronary, and neuro vasculature.
CONTRAINDICATIONS
The Rist™ 079 Radial Access Guide Catheter is contraindicated for use with liquid embolic agents, such as
n-butyl cyanoacrylate, ethylene vinyl alcohol, and dimethyl sulfoxide (DMSO) based materials.
PREPARATIONS FOR USE
1. Select the appropriately sized device based on procedure type and patient anatomy.
2. Grasp the hub and gently remove the Rist™ 079 Radial Access Guide Catheter from its protective tubing.
3. Inspect the product for kinks or other damage. If any damage is observed, replace with a new device.
4. Flush the inner lumen with saline and connect a Hemostasis valve to the hub of the Rist™ 079 Radial
Access Guide Catheter.
IF USING DILATOR:
• Flush and wet the dilator with saline.
• Insert the dilator completely into The Rist™ 079 Radial Access Guide Catheter.
DIRECTIONS FOR USE
1. Gain primary radial artery access using standard technique.
IF NOT USING A SHORT SHEATH:
• Advance the Rist™ 079 Radial Access Guide Catheter/dilator assembly over the guide wire
(0.037inches or 0.94mm or smaller) and advance products into vasculature. Remove the dilator.
IF USING A SHORT SHEATH:
• Advance the Rist™ 079 Radial Access Guide Catheter over the guide wire into the appropriately sized
short sheath. It is recommended to use a shaped catheter/dilator with the Rist™ 079 Radial Access
Guide Catheter to aid insertion into a short sheath.
Insert appropriately sized catheters as needed and advance products to the intended vascular site
under uoroscopic guidance.
2. When use of the Rist™ 079 Radial Access Guide Catheter is complete, remove the product using
standard technique.
3. After use, the device may be a potential biohazard. Handle and dispose of product in accordance with
facility protocol and applicable local, state, and federal laws and regulations.
POTENTIAL COMPLICATIONS
• Air Embolism
• Allergic Reaction
• Death
• Embolism
• False Aneurysm Formation
• Fistula
• Hemorrhage
• Hypersensitivity
• Hypotension
• Infection
• Inammation
• Intracranial hemorrhage
• Ischemia
• Material Left in Patient
• Neurological decit/ dysfunction
• Occlusion
• Organ failure
• Pain And Tenderness
• Radial Artery Occlusion
• Stenosis
• Stroke/ Cerebral infarction
• Therapeutic response decreased
• Thromboembolism
• Thrombus/ Thrombosis
• Vessel Collapse
• Vessel Dissection
• Vessel Perforation or Rupture
• Vessel Spasm/ Vasoconstriction
• Vision symptoms
WARNINGS
• Contents supplied sterile using an ethylene oxide (EO) process. Do not use if sterile barrier is
damaged. If damage is found, call your Medtronic Neurovascular representative.
• Do not use if labeling is incomplete or illegible.
• For single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may
compromise the structural integrity of the device and/or lead to device failure which, in turn, may
result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk
of contamination of the device and/or cause patient infection or cross-infection, including, but not
limited to, the transmission of infectious disease(s) from one patient to another. Contamination of
the device may lead to injury, illness or death of the patient.
• When the Guide Catheter is introduced to the vascular system, it should be manipulated while under
high- quality uoroscopic observation. Do not advance or retract the Guide Catheter if resistance is
met during manipulation; determine the cause of the resistance before proceeding.
• Torquing or moving the device against resistance may result in damage to the vessel or device.
• This device is coated with a hydrophilic coating at the distal end of the device for a length of 25cm.
Please refer to the preparation and directions sections for further information on how to prepare and
use this device to ensure it performs as intended. Failure to abide by the warnings in this labeling
may result in damage to the device coating, which may necessitate intervention or result in serious
adverse events.
• After use, dispose of product and packaging in accordance with hospital, administrative and/or local
government policy.
PRECAUTIONS
1. The Rist™ 079 Radial Access Guide Catheter must only be used by physicians trained in intravascular
intervention.
2. Use the device prior to the “Use By” date specied on the package.
3. Maintain a constant infusion of appropriate ush solution.
4. If ow through the device becomes restricted, do not attempt to clear the lumen by infusion. Remove
and replace the device.
5. Examine the device to verify functionality and to ensure that its size and shape are suitable for the
specic procedure for which it is to be used.
6. The Rist™ 079 Radial Access Guide Catheter should be used only by physicians trained in percutaneous
procedures and/or interventional techniques.
7. Prior to beginning radial artery access, perform an assessment of the collateral circulation of the hand
to ensure that radial access is appropriate for the patient.
8. Limit the exposure to X-ray radiation doses to patients and physicians by using sucient shielding,
reducing uoroscopy times, and modifying X-ray technical factors when possible.
9. Avoid wiping the device with dry gauze as this may damage the device coating.
10. Avoid excessive wiping of the coated device.
11. Avoid using alcohol, antiseptic solutions, or other solvents to pre-treat the device because this may
cause unpredictable changes in the coating which could aect the device safety and performance.
12. Use an appropriate hemostasis valve during the procedure.
HANDLING AND STORAGE
This device should be stored in a dry place, away from sunlight.
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Symbol Glossary
Sterilized using ethylene oxide
Do not re-use
Caution: Federal (USA) law restricts this device to sale by or on the
order of a physician
Do not resterilize
Consult instructions for use at this website
Caution
Do not use if package is damaged
Non-pyrogenic
Keep away from sunlight
Catalogue number
Manufacturer
Use-by date
Batch code
Date of manufacture
Contents of Package
Contains biological material of animal origin
Radial Access Guide Catheter
Dilator
Keep dry
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Micro Therapeutics, Inc.
d/b/a ev3 Neurovascular
9775 Toledo Way
Irvine, CA 92618
USA
Tel: +1.949.837.3700
© 2020 Medtronic. All rights reserved. Medtronic and Medtronic logo are trademarks of Medtronic. All other brands are
trademarks of a Medtronic company.
M009679CDOC2 Rev. B (12/2020)
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